CAPA

Need for CAPA

Pharmaceutical companies are required under ICH Q10, FDA 21 CFR Part 211, EU GMP, and ISO 9001 to implement CAPA processes to identify, investigate, and eliminate quality deviations and prevent their recurrence. A standardized CAPA process ensures systematic identification, investigation, resolution, and prevention of recurring quality issues. Effective CAPA ensures regulatory adherence, minimizes product recalls, and maintains patient safety. Hence, a robust, compliant CAPA system is foundational to pharmaceutical quality systems, enabling compliance, protecting patients, avoiding costly mistakes, and driving sustainable business performance. 

How it Benefits  

Ensures regulatory compliance with global standards such as USFDA, EMA, MHRA, and WHO, reducing the risk of 483s, warning letters, or import alerts

Skill Matrix & Gap Analysis

Ensures that product failures, deviations, and risks are effectively mitigated, preventing defective medicines from reaching patients.

Automated workflows, notifications, and escalation mechanisms to reduce delays in CAPA execution and closure.

Training Extension Forms

Dashboards and analytics provide management with insights into CAPA trends, overdue tasks, and effectiveness, enabling data-driven decisions

audit

Auto linkage with deviations, complaints, and audits, CAPA becomes the backbone of a closed-loop quality management system

Process Diagram

Source Identification and CAPA logging

Acknowledging root cause for Deviation / Incident / Audit Finding / Complaint and initiaton of the CAPA

Preliminary Assessment / Risk Evaluation

Evaluate the criticality and potential impact on product quality, patient safety, and compliance. 

Define Corrective and Preventive Actions

Establish the immediate corrective measures, and determine preventive actions to eliminate the root cause and avoid recurrence. 

CAPA Review & Approval

Evaluation from Cross functional team along with QA for adequacy, feasibility, and compliance impact and approval. 

CAPA Implementation

Implement corrective and preventive actions that addresses the root cause. 

Verification of Effectiveness & Closure

Confirm actions resolved the issue, perform Effectiveness checks and close out documentation. 

Handling of CAPA with QEdge

  • Centralized CAPA Lifecycle Management
  • Controlled Review and Multi-Level Approval
  • Auto-escalation of overdue CAPAs
  • Action Planning and Assignment
  • Inbuilt checks for effectiveness verification

Results of Implementation

CAPA Closure Time reduced up to

0 %

Cross-department collaboration improved by

0 %

Audit readiness improved up to

0 %

Resolution of issues improved up to

0 %

Operational efficiency & Productivity increased up to

0 %